Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis
Status: | Withdrawn |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - 90 |
Updated: | 12/8/2017 |
Start Date: | December 2017 |
End Date: | April 2019 |
Particulate vs. Nonparticulate Epidural Steroid Injections for the Treatment of Symptomatic Unilateral Lumbar Foraminal Stenosis: a Prospective Double-blinded Randomized Study
Chronic lumbosacral radiculopathy secondary to lumbar spinal stenosis affects a large number
of individuals, and there is a general lack of consensus in the medical community in terms of
effective treatments for this problem. By assessing the relative efficacy of transforaminal
epidural injections of particulate and nonparticulate steroids, this study attempts to
further define the appropriate conservative management of painful unilateral radiculopathies
due to unilateral lumbar foraminal stenosis. Patients will be randomized to receive a
transforaminal epidural injection of either a particulate (Kenalog) or nonparticulate
(Decadron) steroid. Outcomes will be assessed at 2 weeks, 6 weeks, 3 months, and 6 months
following the injection.
of individuals, and there is a general lack of consensus in the medical community in terms of
effective treatments for this problem. By assessing the relative efficacy of transforaminal
epidural injections of particulate and nonparticulate steroids, this study attempts to
further define the appropriate conservative management of painful unilateral radiculopathies
due to unilateral lumbar foraminal stenosis. Patients will be randomized to receive a
transforaminal epidural injection of either a particulate (Kenalog) or nonparticulate
(Decadron) steroid. Outcomes will be assessed at 2 weeks, 6 weeks, 3 months, and 6 months
following the injection.
Inclusion Criteria:
- English speaking/reading adults age 18-90 years
- Patients with complaints of unilateral radicular lower extremity symptoms
- NRS pain score >= 5
- Pain symptoms for at least 1 month's duration
- Patients deemed appropriate for lumbar transforaminal epidural steroid injections by
treating spine specialist
- Targeted injection level for L4 or L5
- MRI of lumbosacral spine that demonstrates and confirms single-level neural
compression secondary to unilateral lumbosacral foraminal or subarticular stenosis
consistent with clinical history and findings
- Lumbar foraminal stenosis severity of grades 1, 2, and 3
Exclusion Criteria:
- Patients with multiple symptomatic levels
- Patients who are deemed not appropriate to undergo lumbar transforaminal epidural
steroid injections (e.g., allergy to local anesthetics, radiographic dye contrast,
patients with high bleeding tendency, pregnancy)
- Patients involved with litigation or worker's compensation cases
- Patients who are unable to answer the questionnaires and perform follow-up visits
- Patients who have active, concurrent painful diagnoses (e.g., hip osteoarthritis,
greater trochanteric pain syndrome, knee pain, peripheral vascular disease, or
peripheral neuropathy) that may confuse clinical picture and impact patients' rating
and perception of their low back and radicular symptoms
- Patients with other spinal pathologies confirmed on imaging that may explain patient's
pain
- Patients who have additional severe foraminal stenosis inferior to the symptomatic
level (e.g., symptomatic L4 foraminal stenosis with severe L5 foraminal stenosis) will
not have those levels injected
- Non-English speakers
We found this trial at
1
site
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
Click here to add this to my saved trials